Nykanen Radiofrequency Wire Instructions for Use

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DMR RFP-265 3.3 V-8 24-Sep-2009

English______________________________ Carefully read all instructions prior to use. Observe all contraindications, warnings and precautions noted in these instructions. Failure to do so may result in patient complications.

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Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

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DEVICE DESCRIPTION

The Nykanen Radiofrequency Wire delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) Electrode, which is in compliance with ANSI/AAMI Standard HF-18 and/or ISO 60601-2-2. The Nykanen Wire is connected to the BMC Radiofrequency Puncture Generator via the BMC Catheter Connector Cable (Model RFP-101). Detailed information concerning the BMC Radiofrequency Puncture Generator is contained in a separate manual that accompanies the Generator (entitled “BMC Radiofrequency Puncture Generator Instructions for Use”). The critical dimensions of the Nykanen Wire can be found on the device label. The Teflon insulation on the wire body facilitates smooth advancement through guiding catheters, while the outer diameter is small enough to provide adequate spacing for injection of contrast solution through the guiding catheter. The distal portion of the Nykanen Wire is flexible and the active tip specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied. II.

INDICATIONS FOR USE

The Nykanen Radiofrequency Wire is intended to create an atrial septal defect in the heart. III.

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CONTRAINDICATIONS

The Nykanen Radiofrequency Wire is not recommended for use with any conditions that do not require the creation of an atrial septal defect. IV.

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WARNINGS The Nykanen Wire is supplied STERILE using an ethylene oxide process. Do not use if the package is damaged. Laboratory staff and patients can undergo significant x-ray exposure during radiofrequency puncture procedures due to the continuous usage of fluoroscopic imaging. This exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects. Therefore, adequate measures must be taken to minimize this exposure. The Nykanen Wire is intended for single patient use only. Do not attempt to sterilize and reuse the wire. Reuse can cause the patient injury and/or the communication of infectious disease(s) from one patient to another. Failure to do so may result in patient complications. The Nykanen Wire must be used with the BMC Catheter Connector Cable (Model RFP-101). Attempts to use it with other connector wires can result in electrocution of the patient and/or operator. The active tip of the Nykanen Wire is fragile. Be careful not to damage the tip while handling the wire. If the tip becomes damaged discard the wire immediately. If the active tip of the wire becomes bent at any time during its use, dispose of the wire immediately. Do not attempt to straighten the active tip. Do not attempt to puncture with an initial power setting of greater than 10 watts. The initial attempt should be made with a 10 watts setting. In subsequent attempts, the power setting can be increased, if necessary.

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The RF Puncture Wire is not intended for use with neonatal patients (less than one month of age). Do not attempt to treat neonatal patients with the wire. PRECAUTIONS Do not attempt to use the Nykanen Radiofrequency Wire or ancillary equipment before thoroughly reading the accompanying Instructions for Use. Radiofrequency puncture procedures should be performed only by physicians thoroughly trained in the techniques of radiofrequency powered puncture in a fully equipped catheterization laboratory. The sterile packaging should be visually inspected prior to use to detect any compromise. Ensure that the packaging has not been damaged. Do not use the equipment if the packaging has been compromised. Visually inspect the Nykanen Wire prior to use to ensure there is no cracking or damage to the insulating material. Do not use the wire if there is any damage. Do not use the Nykanen Wire after the “Use By” date indicated on the label. The Nykanen Radiofrequency Wire is intended for use with only those devices listed in section VIII, “Equipment Required.” Read and follow the manufacturer’s instructions for use of the Disposable Indifferent (Dispersive) Patch (DIP) electrode. Always use DIP electrodes that meet or exceed ANSI/AAMI HF-18 and/or ISO 60601-2-2 requirements. Placement of the dispersive electrode on the thigh could be associated with higher impedance. In order to prevent the risk of ignition make sure that flammable material is not present in the room during RF power application. Take precautions to limit the effects that the electromagnetic interference (EMI) produced by the Generator may have on the performance of other equipment. Check the compatibility and safety of combinations of other physiological monitoring and electrical apparatus to be used on the patient in addition to the Generator. Adequate filtering must be used to allow continuous monitoring of the surface electrocardiogram (ECG) during radiofrequency power applications. Careful wire manipulation must be performed to avoid cardiac damage, or tamponade. Wire advancement should be done under fluoroscopic guidance. If resistance is encountered, DO NOT use excessive force to advance or withdraw the wire. Do not attempt to puncture until firm position of the active tip has been achieved against the atrial septum. It is recommended not to exceed five (5) radiofrequency power applications per Nykanen Wire. Do not bend the Nykanen Wire. Excessive bending or kinking of the wire shaft may damage the integrity of the wire and may cause patient injury. Care must be taken when handling the wire. The Generator is capable of delivering significant electrical power. Patient or operator injury can result from improper handling of the wire and DIP electrode, particularly when operating the device. During power delivery, the patient should not be allowed to come in contact with ground metal surfaces. Apparent low power output or failure of the equipment to function properly at normal settings may indicate faulty application of the DIP electrode, failure to an electrical lead, or poor tissue contact at the active tip. Check for obvious equipment defects or misapplication. Attempt to better position the tip of the Nykanen Wire against the atrial septum. Only increase the power if low power output persists. Regularly inspect and test re-usable cables and accessories. Baylis Medical Company relies on the physician to determine, assess and communicate to each individual patient all foreseeable risks of the Baylis Medical Radiofrequency Puncture System. DMR RFP-265 3.3 V-8 24-Sep-2009

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ADVERSE EVENTS

Adverse events which may occur while using the Baylis Medical Radiofrequency Puncture System include: Atrial Fibrillation Atrial Flutter Myocardial Infarction Sustained Arrhythmia VII.

Ventricular Tachycardia Perforation of the myocardium Tamponade

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BMC Radiofrequency Puncture Generator BMC Catheter Connector Cable (Model RFP-101) Disposable Indifferent (dispersive) Patch (DIP) electrode that meets or exceeds ANSI/AAMI standard HF-18 and/or ISO 60601-2-2 requirements for electrosurgical electrodes, such as the Valley Labs Polyhesive Electrode #E7506.

Please refer to the BMC Radiofrequency Puncture Generator Instructions for Use. The Instructions for Use describe the steps to follow to connect the system, set parameters, and deliver radiofrequency power.

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All instructions for equipment required should be carefully read, understood, and followed. Failure to do so may result in complications.

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The Nykanen Wire is supplied sterile. Use aseptic technique when opening the package and handling the product in the sterile field.

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Prior to the insertion of the Nykanen Wire, the usual premedication for cardiac catheterization is necessary.

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The procedure can be done percutaneously via the femoral vein.

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When the procedure is performed by the percutaneous technique, a guiding catheter is used to introduce the Nykanen Wire into the heart to the puncture site.

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Prior to the puncture procedure, both left and right atrial pressure should be recorded and systemic saturation determined.

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The Nykanen Wire is introduced into the right atrium with the location of the wire tip confirmed by fluoroscopic examination.

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Connect the Nykanen Wire to the BMC Catheter Connector Cable (Model RFP-101) ensuring that the Nykanen Wire is inserted properly into the push-button connector. Make sure that the Connector Cable is plugged into the appropriate port on the BMC RF Puncture Generator. Be sure to carefully follow the Generator Instructions for Use.

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Advance the Nykanen Wire so that the active tip is engaging the atrial septum at the fossa ovalis, but still within the guiding catheter (if using). Once appropriate positioning has been achieved, RF power can be delivered via the BMC RF Puncture Generator to the active tip. This results in the puncture of the targeted cardiac tissue. Please refer to the Generator Instructions for Use before using the Generator.

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NOTE: If the active tip of the Nykanen Wire becomes bent at any time during its use, dispose of the wire immediately. Do not attempt to straighten the active tip.

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A power setting of 10 watts has been experimentally determined to be sufficient for successful puncture.

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NOTE: Use the lowest appropriate power setting to achieve the desired puncture. Do not use an initial power setting greater than 10 Watts.

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Firm pressure must be applied to the Nykanen Wire during the procedure to successfully advance it through the tissue.

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RF power delivery can be terminated by pressing the RF ON/OFF button on the Generator if the timer has not expired.

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If septal puncture is not successful after five (5) RF power applications, it is advised that the user proceed with an alternate method for the procedure.

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Once the initial puncture is successfully completed, the Nykanen Wire should be advanced forward mechanically without any radiofrequency power.

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Entry into the left atrium can be confirmed by monitoring the Nykanen Wire under fluoroscopy. Once the guiding catheter has been advanced over the Nykanen Wire, a small injection

SETTING UP THE SYSTEM

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EQUIPMENT REQUIRED

Intracardiac puncture procedures should be performed in a specialized clinical setting equipped with a fluoroscopy unit, radiographic table, physiologic recorder, emergency equipment and instrumentation for gaining vascular access. Ancillary materials required to perform cardiac puncture include:

ATTACHING THE INDIFFERENT ELECTRODE Remove the Disposable Indifferent (dispersive) Patch (DIP) electrode from the packaging and peel off the backing to expose the conductive gel surface. Check to be sure the pad is moist and sticky to the touch before placing it on the patient. A dry electrode will have limited grounding capability. Place the DIP electrode on a well-vascularized convex skin surface which is in close proximity to the heart. Do not place this electrode on the thigh, since this location is associated with higher impedance (see section V, “Precautions”). Avoid scar tissue, body prominence, adipose tissue, and areas where fluid may pool. Shave, clean, and dry the application site as needed. Check to be sure that excellent contact has been achieved over the entire area of the DIP electrode. Burns can result when RF power is delivered to a DIP electrode with poor contact. Plug the DIP electrode connector into the appropriate port on the BMC RF Puncture Generator as per the Generator Instructions for Use. Make sure that the DIP electrode connector is firmly pressed into the socket.

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DIRECTIONS FOR USE

The Nykanen Radiofrequency Wire is usually inserted into the femoral vein and is then positioned into the appropriate chamber of the heart under fluoroscopic guidance. Once appropriate positioning has been achieved, radiofrequency power is delivered via the BMC RF Puncture Generator. This results in the puncture of the targeted cardiac tissue.

INSPECTION PRIOR TO USE

Prior to use of the Baylis Medical Radiofrequency Puncture System, the individual components including the BMC Radiofrequency Puncture Generator, Nykanen Radiofrequency Wire, and the BMC Catheter Connector Cable should be carefully examined for damage or defects, as should all equipment used in the procedure. Do not use defective equipment. Do not reuse the Nykanen Radiofrequency Wire. VIII.

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DMR RFP-265 3.3 V-8 24-Sep-2009

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of contrast medium will indicate that the guiding catheter is now in the left atrium.

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The Nykanen Wire can now be removed from the patient. The puncture should then be enlarged by any appropriate, approved dilation methods. The appropriate user instructions supplied with these different devices should be followed.

There are no warranties of any kind which extend beyond the description of the warranties above. BMC disclaims and excludes all warranties, whether expressed or implied, of merchantability or fitness for a particular use or purpose.

LABELING AND SYMBOLS

Manufacturer EU Authorized Representative Sterile using ethylene oxide

In any claim or lawsuit for damages arising from alleged breach of warranty, breach of contract, negligence, product liability or any other legal or equitable theory, the buyer specifically agrees that BMC shall not be liable for damages, for loss of profits, or for claims of buyer’s customers for any such damages. BMC’s sole liability for damages shall be limited to the cost to buyer of the specified goods sold by BMC to buyer which give rise to the claim for liability.

Use By Attention: consult accompanying documents

Français_____________________________

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Lire attentivement toutes les directives avant l’utilisation. Respectez toutes les contre-indications, avertissements et précautions indiqués dans ces directives. Le non-respect risque de causer des complications pour le patient.

Single Use – Do not reuse

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Lot Number

Le Cathéter de Perforation par Radiofréquences Nykanen livre de l’énergie par radiofréquences (RF) d’une façon monopolaire entre son électrode distal et une électrode passive de retour (DIP) disponible commercialement, qui est en accord avec les normes ANSI/AAMI Standard HF-18 et/ou ISO 60601-2-2. Le Cathéter de Perforation par Radiofréquences Nykanen est branché au générateur de perforation par radiofréquences BMC via le Câble Connecteur pour Cathéter BMC (Modèle RFP-101). Des informations plus détaillées sur le Générateur BMC de perforation par radiofréquences sont incluses dans le manuel qui accompagne le générateur (intitulé “Générateur BMC de perforation par radiofréquences”).

Do Not Use if Packaging is Damaged Keep Away From Sunlight Only for EU member states: Use of this symbol indicates that the product must be disposed of in a way that complies with local and national regulations. For questions regarding recycling of this device please contact your distributor

LIMITED WARRANTIES

Baylis Medical Company warrants that its products are free from defects in original workmanship and materials. BMC warrants that sterile products will remain sterile for a period of three years as labeled as long as the original package remains intact. The Nykanen Radiofrequency Wire is designed for single use only. The Nykanen Radiofrequency Wire is not designed for reuse. If any BMC product is proved to be defective in original workmanship or original materials, BMC, in its absolute and sole discretion, will replace or repair any such product, less charges for transportation and labour costs incidental to inspection, removal or restocking of product. This limited warranty applies only to original factory delivered products which have been used for their normal and intended uses. BMC’s limited warranty shall NOT apply to BMC products which have been resterilized, repaired, altered, or modified in any way and shall NOT apply to BMC products which have been improperly stored or improperly installed, operated or maintained contrary to BMC’s instructions.

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LIMITATION OF LIABILITY FOR DAMAGES

The buyer’s use of this product shall be deemed acceptance of the terms and conditions of these limited warranties, exclusions, disclaimers and limitations of liability for money damages.

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DISCLAIMER AND EXCLUSION OF OTHER WARRANTIES

DESCRIPTION DU DISPOSITIF

Les dimensions pour le Cathéter de Perforation par Radiofréquences Nykanen peuvent être trouvées sur l’étiquette du dispositif. L’isolant Téflon sur le cathéter facilite un avancement fluide dans les cathéters guides, tandis que le diamètre extérieur est assez petit pour fournir un espace adéquat pour la perfusion de solution de contraste via le cathéter guide. Aussi, la portion distale du Cathéter de Perforation par Radiofréquences Nykanen est flexible et le bout actif est spécialement conçu pour être atraumatique aux tissus cardiaques à moins que de l’énergie RF soit appliquée. II.

INDICATIONS D’UTILISATION

Le Cathéter de Perforation par Radiofréquences Nykanen a été conçu pour créer une communication interauriculaire dans le cœur. III.

CONTRE-INDICATIONS

Le Cathéter de Perforation par Radiofréquences Nykanen n’est pas conseillé pour les conditions qui n’exigent pas la création d’une communication interauriculaire.

DMR RFP-265 3.3 V-8 24-Sep-2009